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Legislation Decree
nº 3.718, of January 3rd, 2001
THE
PRESIDENT OF THE REPUBLIC, in the use of the attribution vested in him under article
84, item IV of the Constitution, and, in view of provisions in article 4 of the
Law nº 9.787, of February 10, 1999, Article
1 The dispositions presented in the Annex to the Decree nº 3.675, of November
28th , 2000, shall come into force with the following reading:
III - Technical Report 4.
In case the reference medicine being used during trials shall not be from the
same company of the national reference medicine, neither of any registered company
in behalf of the latter, the company interested on the registration shall present,
besides the certificate of pharmaceutical equivalence, a comparative study of
the dissolution profiles, being used factors f1 and f2 between the generic medicine
and the national reference, as well as the correlation trails in vitro/in vivo,
whenever applicable, or justify its performing. Article
2 This Decree enters into force on the date of its publication.
FERNANDO HENRIQUE CARDOSO This text does not substitute the text published in the Official Journal of the Union of January 4th, 2001.
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